2 Day Seminar: Designing & Sustaining New & Existing Product Stability Testing Program (Orlando, FL - June 7-8, 2018) - ResearchAndMarkets.com
Published: Apr 11, 2018
This seminar will help the attendee gain a better understanding of the requirements of the FDA's Drug Stability Guidelines that is stipulated for new, existing and modified drug products that have an existing or new IND or NDA submission.
This seminar will provide the detailed requirements applicable to the FDA's and 21CFR 514.1(b)(5)(x) expectations which states that an applicant should submit data from stability studies that have been completed as well as information about studies that are underway to substantiate the request for a specific expiration date and provide information on the stability of the drug products FDA's Guidance for Industry.
For this reason, it is important to have clarity and understanding of how to apply this regulation prior to the initiation of a new product stability testing program which includes the protocol design, testing, storage, data management, trending and expiration dating extrapolations and expectations for products in a new or existing IND or NDA application process.
This seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program.
This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product. This is an important part of every business final bottom line or indirectly relationship to their supply and warehouse chain (how long the product can be stored before it can be discarded).
For more information about this conference visit https://www.researchandmarkets.com/research/7c3rx9/2_day_seminar?w=4